1087283

AAMI ST63:2002

Sterilization of health care products - Requirements for the development, validation, and routine control of an industrial sterilization process for medical devices - Dry heat

standard by Association for the Advancement of Medical Instrumentation , 10/01/2002

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Full Description

This standard specifies requirements and guidance for the development, validation, and routine control of dry heat sterilization processes for medical devices. Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may apply to other health care products. This standard does not apply to processes that use infrared or microwaves as the heating medium and does not detail a specified requirement for designation of a medical device as ?sterile.?
 

Product Details

Published:
10/01/2002
ANSI:
ANSI Approved
Number of Pages:
54
File Size:
1 file , 230 KB
Part of:
AAMI STBK10-3
Note:
This product is unavailable in Russia, Ukraine, Belarus
 

Document History

  1. AAMI/ISO 20857:2010/(R)2015


    Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices

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    Sterilization of health care products - Requirements for the development, validation, and routine control of an industrial sterilization process for medical devices - Dry heat

    • Historical Version